MAUDE Adverse Event Report: ARJO (SUZHOU) CO., LTD. ALPHA RESPONSE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 464EUR

Device Problem Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Further analysis is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

The nurse plugged the power cord to the wall outlet.Almost immediately (as she stepped back to the back of the bed) thereafter, the nurse heard a loud bang and a stabbing flame was visible, estimated to be approximately 15 cm high.The hospital's electrical safety devices were activated, causing the mains power to be cut off in that circuit.As a result the power cord plug was melted.No injury was sustained as a result of the event.

Event Description

Following the information provided, the customer received the alpha response system.The device power cord was plugged into the outlet.As the nurse stepped back to the back of the bed, she heard a loud bang and allegedly a flame was visible.The hospital's electrical safety devices were activated, causing the mains power to be cut off in that circuit.The patient was not involved at the time of the event.No injury was sustained.

Manufacturer Narrative

The device inspection revealed that the power cord had a melted hole in the plug as a result of the malfunction and both the wall socket and the power cord pins were contaminated with residues.The power cord was returned to the manufacturer for investigation.The tests performed by the manufacturer confirmed that the residues visible on the cable were composed of the copper from the plug pin and the chlorine, likely originating from the cleaning agent.The simulations performed in different environmental conditions confirmed that the corrosion caused by the chlorine residues on the bottom of plug pins led to the reported issue.The ifu for alpha response 464933en rev.05 informs the user about the appropriate cleaning and disinfection procedures to be applied: ¿make sure the system is clean and dry prior to use or storage.¿ ¿avoid immersing electrical parts in water during the cleaning process.¿ ¿wipe all cleaned surfaces with the solution, then wipe with a cloth moistened in water and dry thoroughly.(¿) ensure the product is dry before storage.¿ arjo device failed to meet its performance specification since the power cord was damaged.The device was not used for a patient treatment when the malfunction occurred.This complaint is deemed reportable due to allegation that the power cord malfunction resulted in melted plug.

• Brand Name: ALPHA RESPONSE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): ARJO (SUZHOU) CO., LTD.; no. 158 fangzhou road, sip; suzhou, jiangsu 21502 4; CH 215024
• MDR Report Key: 11964425
• MDR Text Key: 255042750
• Report Number: 3005619970-2021-00012
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 464EUR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other